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NEW YORK — Ranbaxy Laboratories Ltd. and Teva Pharmaceuticals USA Inc. have entered an agreement on their respectives launches of generic versions of Lipitor, Pfizer’s cholesterol-reducing medication.
Jerusalem-based Teva Pharmaceutical Industries Ltd., parent of Teva Pharmaceuticals USA, said Wednesday that under the pact it will receive a portion of the profits from Ranbaxy’s sales of atorvastatin calcium tablets during Ranbaxy’s 180-day first-to-file exclusivity period. Terms of the agreement weren’t disclosed.
Ranbaxy Pharmaceuticals Inc., the Jacksonville, Fla.-based subsidiary of Indian pharmaceutical giant Ranbaxy, said Wednesday that it has launched atorvastatin in the U.S. market after being cleared by the Food and Drug Administration to manufacture and market the drug.
"Atorvastatin helps millions of Americans manage healthy cholesterol levels, and we are pleased to have received U.S. FDA approval to manufacture and market a safe, effective, affordable and accessible alternative to branded Lipitor," Arun Sawhney, chief executive officer and managing director at Ranbaxy, said in a statement. "We are committed to continuing to expand our portfolio of products offered in the U.S. market for the benefit of patients, prescribers and the U.S. health care system."
On Thursday, Teva announced that the FDA has granted tentative approval for its Abbreviated New Drug Application (ANDA) for atorvastatin calcium tablets and that it expects to ship the product in May 2012, when Ranbaxy’s exclusivity period ends.
Lipitor generated total annual sales of $7.89 billion in the United States through September, according to IMS Health data cited by Ranbaxy.
